Monthly Archives: March 2019

Well, this was completely predictable. As predictable as FDA director Scott Gottlieb being forced out to begin with.

Here is a great story from the New York Times about how tobacco and vaping lobbyists are now “circling” the FDA with Gottlieb’s ouster (and yeah, I’m going to call it an ouster … if it walks like a duck …)

Dr. Gottlieb will depart at the end of this month, following his sudden announcement last week that he would resign, with his plans to toughen regulation of both vaping and smoking unfinished and powerful lobbying forces quietly celebrating the exit of a politically canny administrator who aggressively wielded his regulatory powers.

Opponents are already swooping in, making their case to Congress and reaching out to the White House. A coalition of conservative organizations that oppose government intervention in the marketplace has harshly criticized Dr. Gottlieb’s crackdown on e-cigarettes. Retailers, including convenience store and gas station owners, are on Capitol Hill lobbying against guidelines Dr. Gottlieb proposed on Wednesday to restrict sales of most flavored e-cigarettes to separate adult-only areas and to require age verification of customers.

And major tobacco companies are likely to seize on his departure to try to scuttle his long-term plans to lower nicotine levels in cigarettes to nonaddictive levels and to ban menthol cigarettes, which make up more than a third of the cigarette market and dominate sales to African-Americans. Some longtime officials inside the F.D.A. said privately that they fear these ideas could be delayed indefinitely.

“There have been well-intentioned commissioners before Gottlieb,” said Jonathan Havens, a former F.D.A. tobacco lawyer now in private practice. “But they were not as good at capturing the attention of the nation, of the stakeholders. I think that momentum could very well stall on some of these products, or be lost completely.”

It turns out Altria donated $500,000 to Trump’s inauguration committee and that both Altria and Juul, the largest e-cig brand on the market (which Altria just purchased a controlling share of months ago), have both donated thousands to right-wing lobbying firms run by people like Grover Norquist and others. Juul spent $1.6 million in donations to lobbyists, according to the New York Times.

Gottlieb had also proposed banning menthol cigarettes and forcing cigarette makers to cut the amount of nicotine in their products. Sure enough, it turns out that when asked if the FDA planned to follow through with Gottlieb’s proposals, the response was “no comment.” (I shit you not).

Even with FDA chief Scott Gottlieb stepping down, the agency went ahead this week with its new rules regulating the sales of e-cig products — the big change being the banishment of most fruity flavours.

From now on, only menthol-flavoured cigarettes will be allowed.

Sales of e-cig products will also be restricted to “adult areas” in stores. I have no idea, and I think few people do, how exactly this would work. It sounds like it could literally be a storage closet in the back with a curtain. This was a huge step back from the proposal put forward by Gottlieb a few months ago. He originally proposed that e-cig sales would be restricted solely to tobacco shops, not convenience stores. I liked that idea, because there’s about 1/10th as many tobacco shops as convenience stores.

But, the convenience store industry balked at that and now we have this hybrid policy that no one knows how is going to work.

Unfortunately, with Gottlieb stepping down and a very pro-industry Trump administration in power at the moment, I remain cynical whether the FDA will actually go through with these regulations. Don’t be shocked if this all gets mysteriously dropped in the next few weeks. Gottlieb was a huge advocate (in the Trump administration, weird, huh) against teen smoking and teen vaping. Teen vaping has in particular skyrocketed the past five years, as the largely unregulated vaping industry was absolutely brazen about using friuity, kiddie flavours like bubble gum and Sprite and marketing their products to teens very much like the tobacco industry did 30 and 40 years ago.

FDA Administrator Scott Gottlieb announced this week that he is resigning his position to… get this … spend more time with his family.

Yup, that really actually is his excuse. And this came a couple of weeks after he insisted he wasn’t going anywhere … which was a pretty big clue that he was on his way out.

And he was totally not forced out by Republicans or by the tobacco industry because … he insists he was not forced out by Republicans or the tobacco industry. Repeatedly. So, that’s the end of discussion.

Gottlieb was a total anomaly in the Trump Administration, someone who actually was doing his job. Someone who wasn’t terribly controversial and who didn’t completely dismantle the agency he was put in charge of.

Honestly, for two years, I’ve been scratching my head at it. Trump has clearly put pro-industry, pro-business, anti-regulatory shills in charge of many federal agencies. And it’s clear that their role is to simply dismantle that agency.

Gottlieb was the outlier. He actually was fairly anti-tobacco industry and he was particularly anti-vaping industry (and I don’t differentiate much between the vaping and tobacco industry because the tobacco industry has a controlling interest about 75-80 percent of the vaping industry) was using the FDA to crack down pretty harshly on the vaping industry, mostly over the huge increase in recent years in teen vaping.

Gottlieb had gone so far as to threaten to completely ban vaping products completely. He didn’t follow through with that threat, but he did propose a bunch of new regulations toward vaping products, including rules that vaping products can only be sold in areas completely closed off to minors. He also proposed banning menthol cigarettes.

So, I wasn’t surprised when he suddenly announced this week he was resigning.

Hah, the kicker? He actually boldly announced two months ago he wasn’t going anywhere. That told me right there that there was political pressure coming down on him because he was too anti-industry for Republicans’ taste.

This New York Times article goes to great length to highlight Gottlieb and the Trump Administration’s denials that he was forced out by Big Tobacco and Republicans. He denies it a little too much, frankly. Yeah, because the Trump Administration ALWAYS tells the truth about these things, right? And the “I wanted to spend more time with my family” is the oldest excuse in the book.

Dr. Gottlieb has been subject to increasing pressure from some Republicans in Congress and his former associates in the conservative movement for his tough stance against youth vaping and traditional cigarettes. A coalition of influential conservative groups recently asked the White House to block some key parts of the F.D.A.’s strategy to prevent youths from vaping. Republican Senator Richard Burr blasted the commissioner on the Senate floor for his proposal to ban menthol cigarettes.

Dr. Gottlieb said these protests had no role in his departure.

“There’s no intrigue here,” he said in an interview. A senior White House official said Dr. Gottlieb was not pressured to leave and that the President was “very fond” of him.

Dr. Gottlieb said these protests had no role in his departure.

“There’s no intrigue here,” he said in an interview. A senior White House official said Dr. Gottlieb was not pressured to leave and that the President was “very fond” of him.

Gottlieb’s proposed regulations were in the “pending” stage. Expect them to remain there … or to be dropped entirely. From the article:

Dr. Gottlieb said he planned to advance the F.D.A.’s pending tobacco regulations before he leaves. And he was confident, he said, that the agency’s guidance on restricting flavored e-cigarettes would be issued before he left. He acknowledged, however, that he could not predict the fate of his proposals to ban menthol in cigarettes and reduce nicotine to nonaddictive levels in cigarettes.

Industry analysts expressed optimism that those initiatives would, in fact, now end.

“We think this major development will be broadly viewed as a positive for the tobacco industry, although this introduces some uncertainty,” Bonnie Herzog, a managing director of equity research at Wells Fargo Securities, wrote in an email to clients. “We believe his resignation calls into question whether or not the FDA will in fact enforce harsher regulations around youth e-cig usage/access, cig nicotine limits and a cig menthol ban given he was the champion behind these initiatives.”

So, I expect little or nothing to be done about vaping, teen vaping, menthol cigarettes for the next two years. Gottlieb was the wrong guy, in the wrong administration, to make it happen.